Sarepta sets expectations for gene therapy AdComm

Today's Big News

May 3, 2023

Lilly's hotly anticipated Alzheimer's data set a new high score in slowing cognitive decline


Cerevel to change up CEO as 7 data readouts near showdown


Sarepta, days out from critical FDA meeting, lists questions expected at gene therapy AdComm


Magenta hoists Dianthus onto its shoulders via reverse merger, securing a final lifeline for shareholders after winding down


Pfizer kicks newly acquired meds out of Arena as part of midstage cleaning


Immatics' solid tumor data fan PRAME flame, sending stock soaring


FDA encourages decentralized trials with new guidance 


Radiopharmaceutical company Convergent closes series A to the tune of $90M


Incyte whittles down pipeline, scrapping 6 R&D programs


Fierce Biotech Fundraising Tracker '23: Convergent circles up $90M; ARTHEx raises €42M

 

Featured

Lilly's hotly anticipated Alzheimer's data set a new high score in slowing cognitive decline

Eli Lilly’s Alzheimer’s disease candidate has achieved a 35% slowing of cognitive decline and a 39% lower risk of advancing to the next stage of the disease when compared to placebo.
 

Top Stories

Cerevel to change up CEO as 7 data readouts near showdown

Four years after taking the helm of Cerevel Therapeutics, Tony Coles, M.D., is stepping down, handing the reins over to Ron Renaud as the neuroscience biotech waits on seven data readouts.

Sarepta, days out from critical FDA meeting, lists questions expected at gene therapy AdComm

The clock is ticking down to the FDA advisory committee meeting about Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy SRP-9001. With days to go, Sarepta has set out what is expected to be asked at the meeting—and made the case that it can allay concerns about its confirmatory trial. 

Magenta hoists Dianthus onto its shoulders via reverse merger, securing a final lifeline for shareholders after winding down

Magenta Therapeutics has found a financial exit route months after going on the hunt for a sale, inking a reverse merger with Dianthus Therapeutics. Dianthus is a year removed from a $100 million series A.

Pfizer kicks newly acquired meds out of Arena as part of midstage cleaning

Pfizer is axing a handful of midstage medicines, most of which stemmed from the company's acquisition of Arena Pharmaceuticals. Company executives also noted on its first-quarter earnings call that it remains on the M&A hunt even after acquiring Seagen for almost $50 billion.

Immatics' solid tumor data fan PRAME flame, sending stock soaring

Immatics has posted more evidence that PRAME may live up to its billing as “one of the most promising and most prevalent” solid tumor targets. In updated phase 1b data, the biotech reported a 64% response rate and early signs that its T-cell therapy may have deep and durable effects against cancer cells.

FDA encourages decentralized trials with new guidance

Companies looking to execute decentralized clinical trials should watch out for data variability and precision as information comes in from patients’ homes or local healthcare facilities, according to new FDA guidance. But the agency is otherwise keen to see more of these studies to help boost diversity in clinical research.

Radiopharmaceutical company Convergent closes series A to the tune of $90M

Convergent Therapeutics has circled up $90 million to develop next-gen radiopharmaceuticals in oncology, with its lead clinical program targeting prostate cancer. 

Incyte whittles down pipeline, scrapping 6 R&D programs

Incyte is whittling down its R&D pipeline, scrapping six discovery programs—one in a rare form of anemia and five in various cancers—to focus on eight remaining programs.

Fierce Biotech Fundraising Tracker '23: Convergent circles up $90M; ARTHEx raises €42M

Alongside the new year, we've launched a new Fierce Biotech Fundraising Tracker to keep the pulse on the industry's financing.

GSK staffers kick off series of strikes in UK for the first time in drugmaker's history

Workers at GSK’s Montrose facility in Scotland on Tuesday kicked off a series of strikes that will sequentially affect six of the company’s sites and last throughout May.

FDA: The heart-checking smart toilet seat is a go

Casana—a startup describing itself as “the industry leader in monitoring heart health through smart toilets”—has received a green light for its Heart Seat to log users’ pulse rate and blood oxygen saturation.

Bristol Myers accuses AstraZeneca of infringing patent on cancer blockbuster Opdivo—again

In a new lawsuit between oncology giants, Bristol Myers Squibb claims AstraZeneca willfully infringed a key Opdivo patent.

White House announces end to COVID-19 vaccination requirements for federal employees, healthcare

The Biden administration said that its frequently contested pandemic requirement will run its course on May 11 for federal employees and contractors, while more information for CMS-certified healthcare facilities will be released “in the coming days.”
 
Fierce podcasts

Don't miss an episode

'Podnosis': Healthcare’s relationship to climate change

This week on "Podnosis," we discuss how the healthcare industry is addressing its role in climate change.
 

Resources

eBook

Decentralized Clinical Trials: The Complete Guide for 2023

Discover a game-changing approach to clinical research with Hybrid and Decentralized Clinical Trials (DCTs). Learn about the benefits, challenges, and key elements for success.
Research

How Lilly’s Legal and Library Services Empower Teams Across the Drug Development Pipeline

What role do the Library and Legal teams play in the drug development pipeline at Lilly? An import one – find out how.

Whitepaper

Medical Affairs Metamorphosis VI: The Changing Face of Stakeholder Engagement

This paper focuses on stakeholder engagement and how Medical Affairs teams’ responsibilities, goals, tools, and techniques are changing.
Research

Maximizing Clinical Trial Success

Strategies for Optimal Site Selection and Feasibility Research in Novel Therapies and Geographies
Whitepaper

eConsent: Flexible Consent Through Enabling Technologies

How can eConsent provide a more flexible approach to informed consent?

Whitepaper

Plan for scalable process liquid and buffer preparation

Preparation of critical process liquids and buffer components shifts resources away from core activities and can be filled with inefficiencies and risks that can increase time and costs across your workflow. Learn about the framework to help reduce your total costs beyond capital and operational expenditures and set a solid foundation for successful scale-up of buffer preparation.

Whitepaper

Running Decentralized Trials at Scale

Explore how clinical supply can be scaled up as decentralized programs progress, and how technological solutions can accelerate trial deployment.
Whitepaper

Key Clinical Supply Issues Sponsors Should Consider with their CRO

As sponsors increasingly look to CROs to support their clinical studies, making and addressing certain clinical supply considerations at the outset of the relationship can reduce the risk of potentially unforeseen impact to budget and time later. Discover key issues sponsors should consider to help their CRO or partner of choice better understand their clinical supply needs.

Whitepaper

Specialized Expertise for Management of Clinical Supply Budgets

For sponsors, cost is a key concern when it comes to managing the supply of their clinical trials. A financial project analyst (FPA) is a specialized expert who can help control clinical supply costs and keep the project within budget. Explore the critical role that a Financial Project Analyst plays in clinical trial supply and budget management.
Whitepaper

Clinical Supply Solutions for the Asia-Pacific Region

Learn how Catalent’s extensive network across APAC can meet a wide range of clinical supply needs for sponsors conducting trials within the region.
Whitepaper

Designing an Optimal APAC Clinical Supply Chain

Discover key considerations that every trial sponsor should know when navigating the complex clinical supply distribution landscape across Asia-Pacific.
Whitepaper

Roles and Responsibilities of Specialized Clinical Supply Experts

How can specialized expertise help you optimize your clinical supply chain? Learn about the roles and responsibilities of unique experts such as clinical supply management, project management, and financial project analysis.
Whitepaper

Supply Services to Support Clinical Trials in Japan & Beyond

Explore Catalent’s newest clinical supply facility in Japan, including the comprehensive services & solutions it offers to help support trials both in-country & around the world.
Whitepaper

Questions You Need to Ask Your CRO About Clinical Supply

Planning on using a CRO to support your next clinical study? This infographic outlines critical areas to address at the start of the relationship in order to ensure that budget and timelines keep on track for the duration of the trial.
 

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